An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)

Terminated

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT01604252
• Lead Sponsor: Genentech, Inc.

Brief Summary

This multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-23
• Study Start: 2012-06-20
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• Adult patients, >/= 18 years of age

• Patients with basal cell carcinoma (BCC) who meet either of the following definitions:

  • Patients who were determined with advanced disease (aBCC) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (BCCNS) and have not been treated with an investigational or approved hedgehog pathway inhibitor
  • Patients with aBCC who have not been diagnosed with BCCNS and who were previously treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)
  • Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined by protocol (may include patients previously enrolled in Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP))

Exclusion Criteria

• Participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of aBCC or involved treatment with an investigational or approved hedgehog pathway inhibitor, except for patients treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of response	approximately 5 years
Safety: Incidence of adverse events	approximately 5 years
Recurrence rate	approximately 5 years
Progression-free survival	approximately 5 years
Overall survival	approximately 5 years
Response rate	approximately 5 years

Trial Locations

Locations (81)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Moy-Fincher-Chipps Facial Plastics and Dermatology; 🇺🇸 Beverly Hills, California, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

Scripps Clinic; Hematology & Oncology; 🇺🇸 La Jolla, California, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Fairmont Dermatology Medical Associates, Inc.; 🇺🇸 Lodi, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Dermatology Research Associate; 🇺🇸 Los Angeles, California, United States

Newport Dermatology and Laser Associates; 🇺🇸 Newport Beach, California, United States

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